Xoma Royalty Corporation · NASDAQ:XOMA
Xoma Royalty — XOMA — Investor Presentation (April 2013)
28 slides from Xoma Royalty's investor presentation, April 2013
Slide 1: Corporate Presentation
Corporate Presentation April 2013
Slide 2: Forward-looking Statements
Forward-looking Statements Certain statements contained herein including, but not limited to, statements related to anticipated timing of initiation and completion of clinical trials, anticipated size of clinical trials, therapeutic and market potential of XOMA’s product candidates, continued sales
Slide 3: XOMA's Focus in 2013 & 2014
XOMA’s Focus in 2013 & 2014 Jan’13 1Q13 Mid-13 4Q13 1Q14 2Q14 2H14 NIU NIU Behçet's BLA Phase 3 Phase 3 Uveitis Filing Data Data Phase 3 (YE) Data Proof-of- Concept Acne Scleritis EOA Scleritis (POC) Data Starts Data Data Studies Potential to add rare disease pivotal studies XMet A: Complete develop
Slide 4: Creating Value - Capturing Value
Creating Value - Capturing Value Developing Gevokizumab Creates Expanding Pipeline Creates Value: Value: • Phase 3 NIU/BU program complete in 2014 • Gevokizumab additional indications • Phase 2 POC program to select next Phase • XMet platform 3 indication • Differentiating discovery activities • Rar
Slide 5: Commercial Decision Tree Gives XOMA the Opportunity to Capture Value
Commercial Decision Tree Gives XOMA the Opportunity to Capture Value What diseases might this drug treat? What will the competitive landscape look like if it is approved? If this compound has potential beyond an orphan indication, can we sell it by ourselves to specialty prescribers with a small tar
Slide 6: What XOMA's Future Commercial Audience May Look Like
What XOMA’s Future Commercial Audience May Look Like Rheumatology Ophthalmology Non-infectious uveitis Non-infectious uveitis Erosive osteoarthritis Non-infectious scleritis of the hand Creating and Capturing Dermatology Value Insulin Disorders Specialists Neutrophilic dermatoses Insulinomas Schnitz
Slide 7: Internal Development Pipeline
Internal Development Pipeline Pre- Compound Indication Phase 1 Phase 2 Phase 3 Marketed clinical Gevokizumab Non-infectious uveitis Moderate-to-severe acne Erosive osteoarthritis of the hand Non-infectious Scleritis XMet A Type 1 & 2 diabetes mellitus XMet S Type 2 diabetes mellitus XMet D Excess in
Slide 8: Gevokizumab's Potential Best-in-Class IL-1β Antibody Profile
Gevokizumab’s Potential Best-in-Class IL-1β Antibody Profile High-affinity, humanized allosteric modulating antibody with subcutaneous monthly dosing Distinct properties differentiate gevokizumab from other biologics that inhibit the IL-1 cascade • Elevated levels of IL-1β play a role in many ac
Slide 9: Uveitis: Inflammation of the Uvea
Uveitis: Inflammation of the Uvea Uveitis can be infectious or non- infectious Non-infectious uveitis (NIU) can be anterior, intermediate, posterior or pan – Multiple etiologies; Behçet's uveitis is representative of multiple forms In general, only non-anterior NIU warrants treatment with syst
Slide 10: Clinical Activity in First Trial of Behçet's Subset of Non-Infectious Uveitis
Clinical Activity in First Trial of Behçet's Subset of Non-Infectious Uveitis All 7 patients showed rapid treatment effect for intraocular inflammatory attack 5 of 5 responded to second dose Gevokizumab was well-tolerated 4 patients treated monthly for >2 years • Maintained therapeutic gevok
Slide 11: Rapid Response in Behçet's Subset of NIU
Rapid Response in Behçet’s Subset of NIU hypopyon off-center iris Day 0: Day 1: Day 4: Flare score: 467 ph/msec * Flare score: 45 ph/msec Flare score: 62 ph/msec Anterior chamber cell: 4+ Anterior chamber cell: 4+ Anterior chamber cell: 4+ Vitreous haze: 3+ Vitreous haze: 3+ Vitreous haze: 2+ Fundus
Slide 12: Single Dose Cleared Vitreous Haze in Posterior Uveitis Case
Single Dose Cleared Vitreous Haze in Posterior Uveitis Case 12
Slide 13: YE 2013 & 1H 2014: Anticipated Gevokizumab Phase 3 Data Announcements
YE 2013 & 1H 2014: Anticipated Gevokizumab Phase 3 Data Announcements EYEGUARD-A EYEGUARD-B EYEGUARD-C (XOMA) (Servier) (XOMA) Active/Controlled Active Controlled Controlled # Patients 300 110 300 # Sites 100-120 50 ~120 30mg, 60mg 60mg 30mg, 60mg Gevokizumab doses Placebo Placebo Placebo Randomizat
Slide 14: Gevokizumab Programs Proceeding on Schedule
Gevokizumab Programs Proceeding on Schedule Phase 3 EYEGUARD program • Jointly performed by XOMA and Servier (50/50 cost share) • Manufacturing transferred to Boehringer Ingelheim Servier-sponsored POC program • Launched POC study in ACS December 2012 • XOMA has option rights XOMA-sponsored PO
Slide 15: Jan 2013: Gevokizumab Phase 2 Acne Vulgaris POC Study Top-Line Results
Jan 2013: Gevokizumab Phase 2 Acne Vulgaris POC Study Top-Line Results Patient population >100 patients with moderate to severe acne vulgaris Randomization 1:1:1 Gevokizumab dose 0.2 mg/kg, 0.6 mg/kg vs. placebo dosed once a month Total doses 3 Study initiated December 2011 Top-line data January 201
Slide 16: Acne: Overall Effect on Lesion Count
Acne: Overall Effect on Lesion Count Gevokizumab Moderate to Severe Acne Vulgaris POC Study Inflammatory Lesion Count n=31 n=32 n=29 n=23 n=26 n=25 (1st dose) (2nd dose) (3rd dose) Baseline Inflammatory Lesion Count: 30.6 30.6 31.0 Treatment was dose dependent. Subject mean weight ranged between 72
Slide 17: Acne: High Dose Reached Statistical Significance for Lesion Count at Day 42
Acne: High Dose Reached Statistical Significance for Lesion Count at Day 42 Gevokizumab Moderate to Severe Acne Vulgaris POC Study Inflammatory Lesion Count (Placebo vs. High Dose) n=31 n=29 n=31 n=29 n=29 n=23 LS Mean Difference = 5.8 ± 3.25 n=26 p-value = 0.077 n=25 n=29 n=25 (1st dose) (2nd dose)
Slide 18: Acne: Statistically Significant Improvement in Investigator Global Assessment score at Day 84
Acne: Statistically Significant Improvement in Investigator Global Assessment score at Day 84 Gevokizumab Moderate to Severe Acne Vulgaris POC Study Treatment Responders at Day 84 p-value = 0.031 31% p-value = 1 8% 5% n=21 n=26 n=26 Treatment responders are defined as two or more improvement in the
Slide 19: Mid 2013: Erosive Osteoarthritis of the Hand (EOA) Study Completes
Mid 2013: Erosive Osteoarthritis of the Hand (EOA) Study Completes Subset of osteoarthritis of the hand, affecting several million patients in U.S. In situ analysis of affected tissues (synovium, cartilage, bone) show presence of IL-1β involvement Studies have shown patients typically have ele
Slide 20: Mid 2013: Erosive, Inflammatory Osteoarthritis of the Hand (EOA) Data Read Out
Mid 2013: Erosive, Inflammatory Osteoarthritis of the Hand (EOA) Data Read Out Patient population 90 patients with active EOA Randomization 2:1 Gevokizumab dose 60 mg vs. placebo dosed once a month Total doses 6 Study initiated June 2012 Anticipated top-line Mid 2013 results Improvement in total AUS
Slide 21: Rare Disease Opportunity: Gevokizumab
Rare Disease Opportunity: Gevokizumab Two related rare dermatologic indications to be explored Neutrophilic dermatoses Schnitzler Syndrome • Syndrome comprised of multiple diseases • Characterized by urticaria (hives), including Sweets Disease, Pyoderma periodic fever, bone pain, joint pain, Gangren
Slide 22: XMet Program
XOMA XMet Program
Slide 23: Creating Value from Discovery
Creating Value from Discovery Investing to Capture Value from Future XMet Partnership Agreement XMet A: selective insulin receptor XMet S: insulin sensitizing modulator (SIRM) antibodies • May provide a long-acting alternative • May enable more effective use of own to basal insulin1 insulin for
Slide 24: XMet D: Unique Potential Therapeutic Opportunities
XMet D: Unique Potential Therapeutic Opportunities Antagonist (Deactivator) of the insulin receptor 3 potential rare disease indications to be evaluated: • Insulinomas • Congenital Hyperinsulinism • Hyperinsulinemic Hypoglycemia Post Gastric Bypass Surgery Patients treated in limited number of
Slide 25: Expanded Pipeline
Expanded Pipeline Pre- Compound Indication Phase 1 Phase 2 Phase 3 Marketed clinical Gevokizumab Non-infectious uveitis Moderate-to-severe acne Erosive osteoarthritis of the hand Non-infectious Scleritis Neutrophilic dermatoses Schnitzler syndrome XMet A Type 1 & 2 diabetes mellitus XMet S Type 2 di
Slide 26: Financial Highlights
Financial Highlights $85.3 million cash at December 31, 2012 • Cash runway through 2014 • Cash through Phase 3 EYEGUARD top-line data readouts Approximately 83 million shares outstanding Approximately 72% institutional ownership 2013 guidance: • Cash used in ongoing operating activities will
Slide 27: 2013 & 2014 Focus
2013 & 2014 Focus Jan’13 1Q13 Mid-13 4Q13 1Q14 2Q14 2H14 NIU NIU Behçet's BLA Phase 3 Phase 3 Uveitis Filing Data Data Phase 3 (YE) Data POC Acne Scleritis EOA Scleritis Studies Data Starts Data Data Potential to add rare disease pivotal studies XMet A: Complete development through higher species PO
Slide 28: XOMA
XOMA